Will the 21st Century Cures Act Help or Hinder Secondary Use of Health Data?
The 21st Century Cures Act is proposed legislation that aims to accelerate the discovery, development and delivery of life-saving therapies for patients. The focus of this bill is not patient privacy, but it has privacy implications. Five provisions would impact existing HIPAA legislation covering the use and disclosure of protected health information (PHI). It is unclear whether these provisions will foster new research or, in fact, be a detriment to patient privacy.
The Act passed the House of Representatives and is now headed to the Senate. This bill will have significant impact on health research and patient privacy. There are some good things in the Act, such as pushes to improve research collaboration, modernize clinical trials, and increase funding for the National Institutes of Health (NIH) and Food and Drug Administration (FDA). There are also concerns for what these changes mean when it comes to the rigor and evidence requirements for the approval of drugs and medical devices. This bill also means changes to HIPAA that affect privacy and how patient information is shared.
This white paper is written to review the real implications of the Act and offer solid critique around what this means for HIPAA and HITECH.
Situation: California’s Consumer Privacy Act inspired Comcast to evolve the way in which they protect the privacy of customers who consent to share personal information with them.
Situation: Integrate.ai’s AI-powered tech helps clients improve their online experience by sharing signals about website visitor intent. They wanted to ensure privacy remained fully protected within the machine learning / AI context that produces these signals.
Situation: Novartis’ digital transformation in drug R&D drives their need to maximize value from vast stores of clinical study data for critical internal research enabled by their data42 platform.
Situation: CancerLinQ™, a subsidiary of American Society of Clinical Oncology, is a rapid learning healthcare system that helps oncologists aggregate and analyze data on cancer patients to improve care. To achieve this goal, they must de-identify patient data provided by subscribing practices across the U.S.
Situation: Needed to ensure the primary market research process was fully compliant with internal policies and regulations such as GDPR.
Situation: Needed to enable AI-driven product innovation with a defensible governance program for the safe and responsible use
of voice-to-text data under Shrems II.
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